System and method for sealing an incisional wound

Abstract

An apparatus, system, and method for treating an incisional wound having incisional walls is disclosed. The apparatus includes a conduit having a first end for receiving reduced pressure and a second end. The apparatus further includes a scaffold. The scaffold has opposing surfaces for positioning adjacent the incisional walls and is fluidly coupled to the second end of the conduit for receiving the reduced pressure. The scaffold is generally elongated in shape and has a thickness between the opposing surfaces that is sufficiently thin for positioning within the incisional wound. The apparatus further includes an internal manifold that has a primary flow channel extending generally longitudinally within the scaffold and between the opposing surfaces of the scaffold. The internal manifold is fluidly coupled to the second end of the conduit. The application of the reduced pressure through the scaffold and the internal manifold induces tissue apposition between the incisional walls.

We claim: 
     
       1. An apparatus for treating an incisional wound having incisional walls, the apparatus comprising:
 a conduit having a first end for receiving reduced pressure and a second end; 
 a scaffold having opposing surfaces for positioning adjacent the incisional walls and fluidly coupled to the second end of said conduit for receiving the reduced pressure, said scaffold being generally elongated in shape and having a thickness between the opposing surfaces sufficiently thin for positioning within the incisional wound; and 
 an internal manifold having a primary flow channel extending generally longitudinally within said scaffold between the opposing surfaces and fluidly coupled to the second end of said conduit, wherein the primary flow channel is formed by a bioresorbable tubing; 
 whereby application of the reduced pressure through said scaffold and said internal manifold induces tissue apposition between the incisional walls. 
 
     
     
       2. The apparatus of  claim 1 , wherein the internal manifold further comprises tributary flow channels fluidly coupled to the primary flow channel and extending generally transversely within said scaffold between the opposing surfaces. 
     
     
       3. The apparatus of  claim 2 , wherein the tributary flow channels extend generally perpendicular from the primary flow channel. 
     
     
       4. The apparatus of  claim 2 , wherein one or more of the tributary flow channels originate from a single location within the primary flow channel. 
     
     
       5. The apparatus of  claim 1 , wherein the primary flow channel is an anisotropic property of said scaffold. 
     
     
       6. The apparatus of  claim 1 , wherein the primary flow channel is formed by an alignment of interconnected pores of said scaffold. 
     
     
       7. The apparatus of  claim 1 , wherein the thickness of said scaffold is less than about 3.0 mm. 
     
     
       8. The apparatus of  claim 1 , wherein the thickness of said scaffold is greater than about 0.25 mm. 
     
     
       9. The apparatus of  claim 1 , wherein a ratio of a length to the thickness of said scaffold is greater than about 10. 
     
     
       10. The apparatus of  claim 1 , wherein said scaffold further comprises an edge portion configured not to be in contact with the incisional walls and an external manifold in fluid communication with the edge portion and fluidly coupled to the second end of said conduit. 
     
     
       11. The apparatus of  claim 10 , wherein said external manifold is positioned outside the incisional wound. 
     
     
       12. The apparatus of  claim 1 , wherein the scaffold is bioresorbable. 
     
     
       13. The apparatus of  claim 1 , wherein the scaffold is formed from polylactide-co-glycolide. 
     
     
       14. The apparatus of  claim 1 , wherein said scaffold is formed from resorbable polyurethane. 
     
     
       15. The apparatus of  claim 1 , wherein said scaffold is formed from decellularized biological material. 
     
     
       16. The apparatus of  claim 1 , wherein the scaffold is formed from collagen. 
     
     
       17. The apparatus of  claim 1 , wherein the scaffold is a reticulated structure. 
     
     
       18. The apparatus of  claim 1 , further comprising: an external manifold in fluid communication with a portion of the scaffold; and a drape formed of substantially impermeable material to cover said external manifold and said scaffold within the incisional wound. 
     
     
       19. A system for treating an incisional wound having incisional walls, the system comprising:
 a pressure source to supply reduced pressure; 
 a conduit fluidly coupled to the pressure source having a first end for receiving the reduced pressure and a second end; 
 a scaffold fluidly coupled to the second end of said conduit for receiving the reduced pressure and having a length, a width, and a thickness defined by opposing surfaces for positioning within the incisional wound adjacent the incisional walls, said scaffold being formed from a porous material generally elongated in shape for positioning within the incisional wound the thickness being less than the length and the width; and 
 an internal manifold having a primary flow channel extending generally longitudinally within said scaffold between the opposing surfaces and fluidly coupled to the second end of said conduit, wherein the primary flow channel is formed by an alignment of interconnected pores of said scaffold; 
 whereby application of the reduced pressure through said scaffold and said internal manifold induces tissue apposition between the incisional walls. 
 
     
     
       20. The system of  claim 19 , wherein the internal manifold comprises tributary flow channels fluidly coupled to the primary flow channel and extending generally transversely within said scaffold between the opposing surfaces. 
     
     
       21. The system of  claim 20 , wherein the tributary flow channels extend generally perpendicular from the primary flow channel. 
     
     
       22. The system of  claim 19 , wherein one or more of the tributary flow channels originate from a single location within the primary flow channel. 
     
     
       23. The system of  claim 19 , wherein the primary flow channel is an anisotropic property of said scaffold. 
     
     
       24. The system of  claim 19 , wherein the primary flow channel is formed by bioresorbable tubing. 
     
     
       25. The system of  claim 19 , wherein said scaffold further comprises an edge portion configured not to be in contact with the incisional walls and an external manifold structure in fluid communication with the edge portion and fluidly coupled to the second end of said conduit. 
     
     
       26. The system of  claim 25 , wherein the incisional wound has an opening between the incisional walls and the edge portion is exposed through the opening. 
     
     
       27. The system of  claim 26 , wherein said external manifold is positioned outside the incisional wound. 
     
     
       28. The system of  claim 19 , wherein the incisional wound has an opening between the incisional walls and further comprises means for substantially closing the opening. 
     
     
       29. The system of  claim 19 , further comprising:
 an external manifold in fluid communication with a portion of the scaffold; and 
 a drape formed of substantially impermeable material to cover said external manifold and said scaffold within the incisional wound. 
 
     
     
       30. The system of  claim 19 , further comprising a fluid source fluidly connected to the scaffold. 
     
     
       31. A system for treating an incisional wound having incisional walls, the system comprising:
 a pressure source to supply reduced pressure; 
 a conduit fluidly coupled to the pressure source having a first end for receiving the reduced pressure and a second end; 
 a scaffold fluidly coupled to the second end of said conduit for receiving the reduced pressure and having opposing surfaces for positioning within the incisional wound adjacent the incisional walls, said scaffold being formed from a porous material generally elongated in shape for positioning within the incisional wound, said scaffold having a thickness greater than about 0.25 mm and less than about 3.0 mm; and 
 an internal manifold comprising:
 a primary flow channel extending generally longitudinally within said scaffold between the opposing surfaces and fluidly coupled to the second end of said conduit, wherein the primary flow channel is formed by bioresorbable tubing; and 
 tributary flow channels fluidly coupled to the primary flow channel and extending generally transversely within said scaffold between the opposing surfaces, the tributary flow channels extending generally perpendicular from the primary flow channel; 
 
 whereby application of the reduced pressure through said scaffold and said internal manifold induces tissue apposition between the incisional walls. 
 
     
     
       32. The system of  claim 31 , further comprising:
 an external manifold in fluid communication with a portion of the scaffold; and 
 a drape formed of substantially impermeable material to cover said external manifold and said scaffold within the incisional wound. 
 
     
     
       33. An apparatus for treating an incisional wound having incisional walls, the apparatus comprising:
 a scaffold having a length, a width, and opposing surfaces for positioning adjacent the incisional walls, said scaffold being generally elongated in shape and having a thickness between the opposing surfaces that is less than the length and the width and is sufficiently thin for positioning within the incisional wound; 
 an internal manifold having a primary flow channel extending generally longitudinally within said scaffold between the opposing surfaces for fluidly coupling to a reduced pressure source; 
 an external manifold in fluid communication with a portion of the scaffold; and 
 a drape formed of substantially impermeable material to cover said external manifold and said scaffold within the incisional wound. 
 
     
     
       34. The apparatus of  claim 33 , wherein the internal manifold further comprises tributary flow channels fluidly coupled to the primary flow channel and extending generally transversely within said scaffold between the opposing surfaces. 
     
     
       35. The apparatus of  claim 34 , wherein the tributary flow channels extend generally perpendicular from the primary flow channel. 
     
     
       36. The apparatus of  claim 34 , wherein one or more of the tributary flow channels originate from a single location within the primary flow channel. 
     
     
       37. The apparatus of any of  claims 33  to  36 , wherein the primary flow channel is an anisotropic property of said scaffold. 
     
     
       38. The apparatus of any of  claims 33  to  36  and  37 , wherein the primary flow channel is formed by bioresorbable tubing. 
     
     
       39. The apparatus of any of  claims 33  to  36 ,  37  and  38 , wherein the primary flow channel is formed by an alignment of interconnected pores of said scaffold. 
     
     
       40. The apparatus of any of  claims 33  to  36  and  37  to  39 , wherein the thickness of said scaffold is less than about 3.0 mm. 
     
     
       41. The apparatus of any of  claims 33  to  36  and  37  to  40 , wherein the thickness of said scaffold is greater than about 0.25 mm. 
     
     
       42. The apparatus of any of  claims 33  to  36  and  37  to  41 , wherein a ratio of a length to the thickness of, said scaffold is greater than about 10. 
     
     
       43. The apparatus of any of  claims 33  to  36  and  37  to  42 , wherein said scaffold further comprises an edge portion configured not to be in contact with the incisional walls and an external manifold in fluid communication with the edge portion and fluidly coupled to the second end of said conduit. 
     
     
       44. The apparatus of  claim 43 , wherein said external manifold is positioned outside the incisional wound. 
     
     
       45. The apparatus of any of  claims 33  to  36  and  37  to  44 , wherein the scaffold is bioresorbable. 
     
     
       46. The apparatus of any of  claims 33  to  36  and  37  to  45 , wherein the scaffold is formed from polylactide-co-glycolide. 
     
     
       47. The apparatus of  claim 46 , wherein said scaffold is formed from resorbable polyurethane. 
     
     
       48. The apparatus of  claim 47 , wherein said scaffold is formed from decellularized biological material. 
     
     
       49. The apparatus of any of  claims 33  to  36  and  37  to  48 , wherein the scaffold is formed from collagen. 
     
     
       50. The apparatus of any of  claims 33  to  36  and  37  to  49 , wherein the scaffold is a reticulated structure. 
     
     
       51. The apparatus of any of  claims 33  to  36  and  37  to  50 , further comprising a conduit for fluidly coupling to the primary flow channel. 
     
     
       52. The apparatus of  claim 51 , further comprising a reduced pressure source fluidly coupled to the conduit. 
     
     
       53. An apparatus for treating an incisional wound having incisional walls, the apparatus comprising:
 a conduit having a first end for receiving reduced pressure and a second end; 
 a scaffold having a length, a width, and opposing surfaces for positioning adjacent the incisional walls and fluidly coupled to the second end of said conduit for receiving the reduced pressure, said scaffold being generally elongated in shape and having a thickness between the opposing surfaces that is less than the length and the width and is sufficiently thin for positioning within the incisional wound; and 
 an internal manifold having a primary flow channel extending generally longitudinally within said scaffold between the opposing surfaces and fluidly coupled to the second end of said conduit, wherein the primary flow channel is formed by an alignment of interconnected pores of said scaffold; 
 whereby application of the reduced pressure through said scaffold and said internal manifold induces tissue apposition between the incisional walls. 
 
     
     
       54. An apparatus for treating an incisional wound having incisional walls, the apparatus comprising:
 a scaffold having opposing surfaces for positioning adjacent the incisional walls, said scaffold being generally elongated in shape and having a thickness between the opposing surfaces sufficiently thin for positioning within the incisional wound; and 
 an internal manifold having a primary flow channel extending generally longitudinally within said scaffold between the opposing surfaces for fluidly coupling to a reduced pressure source, wherein the primary flow channel is formed by bioresorbable tubing. 
 
     
     
       55. An apparatus for treating an incisional wound having incisional walls, the apparatus comprising:
 a scaffold having a length, a width, and opposing surfaces for positioning adjacent the incisional walls, said scaffold being generally elongated in shape and having a thickness between the opposing surfaces that is less than the length and the width and is sufficiently thin for positioning within the incisional wound; and 
 an internal manifold having a primary flow channel extending generally longitudinally within said scaffold between the opposing surfaces for fluidly coupling to a reduced pressure source, wherein the primary flow channel is formed by an alignment of interconnected pores of said scaffold.